PMA P030029

Device: ADVIA CENTAUR ANTI-HBS ASSAY
Applicant: Siemens Healthcare Diagnostics
PMA number: P030029
Supplement: S013
Product code: LOM
Decision date: 2012-10-15
Classification: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.

Current openFDA PMA Record#

Device: ADVIA CENTAUR ANTI-HBS ASSAY
Applicant: Siemens Healthcare Diagnostics
PMA number: P030029
Supplement: S013
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2012-10-15
Decision code: APPR
Date received: 2012-03-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.